Меню
Идёт набор NCT06856174

Menopausal HT for Women Living With HIV (HoT)

Фаза IV С лечением HIV Infection Menopause

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transdermal estradiol gel, Micronized Progesterone, Placebo for estradiol gel, Placebo for micronized progesterone.
Кому может быть актуально
Состояния в реестре: HIV Infection, Menopause. Базовые параметры: 40 лет — 60 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Menopausal Hormone Therapy for Women Living With HIV (HoT)

Обзор

Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life. Hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV. This trial is being done to see if: * There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV * Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV * Hormone therapy is safe and tolerable for women living with HIV

Вмешательства

  • Препарат Transdermal estradiol gel
    All participants: Estradiol gel 0.1%, 0.75 grams (corresponding to estradiol 0.75 mg) applied to the skin of the upper thigh once daily for 12 weeks.
  • Препарат Micronized Progesterone
    Participants with intact uterus: Encapsulated micronized progesterone 100 mg orally once daily for 12 weeks.
  • Препарат Placebo for estradiol gel
    All participants: Placebo for estradiol gel 0.1%, 0.75 grams applied to the skin of the upper thigh once daily for 12 weeks.
  • Препарат Placebo for micronized progesterone
    • Participants with intact uterus: Encapsulated placebo for micronized progesterone 100 mg orally once daily for 12 weeks.

Первичные конечные точки

  • Change in vasomotor symptoms (VMS) frequency [Срок оценки: From 5 weeks prior to randomization to Week 12]
Вторичные конечные точки (12)
  • Change in vasomotor symptom (VMS) severity [Срок оценки: From 5 weeks prior to randomization to week 12]
  • Change in sleep [Срок оценки: From randomization to week 12]
  • Change in insomnia [Срок оценки: From randomization to week 12]
  • Change in quality of life [Срок оценки: From randomization to week 12]
  • Percentage of participants with adverse events associated with hormone therapy [Срок оценки: From randomization to week 12]
  • Percentage of participants with occurrence of abnormal vaginal bleeding [Срок оценки: From randomization to week 12]
  • Percentage of participants with intolerance of hormone therapy [Срок оценки: From randomization to week 12]
  • Change in neurocognitive test results [Срок оценки: From randomization to week 12]
  • Change in depression symptoms [Срок оценки: From randomization to week 12]
  • Change in anxiety symptoms [Срок оценки: From randomization to week 12]
  • Change in weight [Срок оценки: From randomization to week 12]
  • Change in body mass index (BMI) [Срок оценки: From randomization to week 12]

Критерии участия

  • Living with HIV
  • Assigned female sex at birth
  • Between the ages of 40 and 60 years
  • In the late menopausal transition (perimenopause) or early postmenopause
  • Experiencing hot flashes and/or night sweats
  • Willing and able to complete a daily diary
  • Does not have medical condition that would contraindicate hormone therapy
  • Not taking medications to treat hot flashes
  • Not taking medications that cannot be combined with hormone therapy
  • Receiving antiretrovirals (HIV medication) for more than 1 year
  • Not pregnant and willing and able to use at least non-hormonal birth control to prevent pregnancy
  • Willing and able to provide informed consent after discussion with the research staff

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 23 центра
  • 31788 Alabama CRS — Birmingham
  • University of California, Los Angeles CARE Center CRS (601) — Los Angeles
  • UCSD Antiviral Research Center CRS (701) — San Diego
  • 801 University of California, San Francisco HIV/AIDS CRS — San Francisco
  • Harbor - UCLA Med. Ctr. CRS — Torrance
  • University of Colorado Hospital CRS (6101) — Aurora
  • The Ponce de Leon Center CRS (5802) — Atlanta
  • Northwestern University CRS (2701) — Chicago
  • … и ещё 15 центров

Идентификаторы

NCT: NCT06856174 · ACTG A5424 · UM1AI068636

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗